DIASEM: Correlation of Muscle Ultrasound Measures (2D and 3D) With Biphotonic X-ray Absorptiometry in Oldest Old Patients.

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04753450
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 15.7
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

The sarcopenia diagnosis is based on the muscle mass and on impaired physical performance. The emerging field of ultrasound assessment of muscle mass in older patients is based on 2d parameters with prediction equations for muscle mass. For the moment, validation of prediction equations in older adults with varying function and health is lacking. The study aims to evaluate correlation of muscle mass between 3D muscle mass measurement and DXA, in order to dispense with the prediction equation.

Condition or Disease	Intervention/Treatment	Phase
Assessment, Self; Muscle Atrophy; Ultrasound Therapy; Complications; Aging	Other: No intervention

Detailed Description

Older patients who agree to participate to the study will undergo 3D ultrasound muscle mass measurement, 2D panoramic mode muscle mass measurement and biphotonic X-ray absorptiometry assessment. Correlation analysis will be done with the different measurement.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Correlation of Muscle Ultrasound Measures (2D and 3D) With Biphotonic X-ray Absorptiometry in Oldest Old Patients.
• Actual Study Start Date: Mar 9, 2021
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Outcome Measures

Primary Outcome Measures

1. 3D Correlation between muscle volume measured by 3D ultrasound and standard method : DXA results [1 week]

   Correlation between muscle volume measured by 3D ultrasound and standard method : DXA results

Secondary Outcome Measures

1. 2D correlation between muscle volume measured by 2D ultrasound and standard method : DXA results [1 week]

   Correlation between muscle volume measured by 2D ultrasound and standard method : DXA results

Eligibility Criteria

Criteria

• Ages Eligible for Study: 75 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients over 75 years old

• Osteoporosis diagnosis confirmed by Dual-energy X-ray Absorptiometry

Exclusion Criteria:

• Neurocognitive disorders preventing the expression of informed consent

• Patients who cannot undergo an examination in a static position

• Lack of a measurement site (muscle resection or amputation)

• Any state of dehydration or water inflation

• Patient with legal protection measure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nantes	Nantes		France

Sponsors and Collaborators

• Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT04753450
• Other Study ID Numbers: RC20_0534
• First Posted: Feb 15, 2021
• Last Update Posted: Jul 16, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Muscular Atrophy

Study Results

No Results Posted as of Jul 16, 2021